COOL-AMI EU Case Series Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by ZOLL Circulation, Inc., USA
Sponsor:
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA
ClinicalTrials.gov Identifier:
NCT02070913
First received: September 24, 2013
Last updated: June 26, 2014
Last verified: June 2014

September 24, 2013
June 26, 2014
September 2013
September 2014   (final data collection date for primary outcome measure)
  • Time from hospital arrival to Percutaneous Coronary Intervention (PCI). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time from hospital arrival to initiation of cooling. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving target temperature. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02070913 on ClinicalTrials.gov Archive Site
Proportion of those enrolled that complete the study protocol. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
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COOL-AMI EU Case Series Clinical Study
COOL-AMI EU Case Series Clinical Study: A Single-Center Case Series Clinical Study to Assess the Feasibility of Integrating Therapeutic Hypothermia Using the ZOLL IVTM System as an Adjunctive Therapy to Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less. The study objectives are to evaluate retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM System.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients who present with clinical signs and symptoms of acute myocardial infarction and meet all Inclusion and Exclusion criteria will be considered for case study presentation in this clinical trial without regard to age, gender or ethnicity.

Acute Myocardial Infarction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient is 18 years of age.
  • The patient must have symptoms consistent with AMI
  • MI with ST-segment elevation
  • The patient is eligible for PCI.
  • The expected timing of the treatment pathway for the patient will allow for at least 10 minutes of cooling with the IVTM System prior to PCI.
  • The patient or patient legal representative is willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

  • The patient has had a previous myocardial infarction
  • The patient is experiencing cardiogenic shock
  • The patient is experiencing acute pulmonary edema.
  • The patient is presenting with cardiac arrest.
  • The patient is presenting with Killip risk stratification class II through IV.
  • The patient is presenting with Atrial Fibrillation.
  • The patient has a history of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
  • The patient requires an immediate surgical or procedural intervention other than PCI
  • The patient has an aortic dissection.
  • The patient has hepatic failure.
  • The patient has end stage kidney disease.
  • The patient is febrile
  • Known chronic Congestive Heart Failure (CHF).
  • Known previous CABG.
  • Known recent stroke
  • Cardio-pulmonary decompensation that has occurred en route to the hospital
  • Contraindications to hypothermia
  • The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
  • The patient has a known history of coagulopathy
  • The patient is known to be pregnant
  • The patient has a known hypersensitivity to antishivering medications.
  • Patient has a known history of severe hepatic or renal impairment.
  • The patient has an Inferior Vena Cava filter in place (IVC).
  • The patient has a life expectancy of less than 1 year
  • The patient has a known, unresolved history of drug use
  • The patient is currently enrolled another investigational drug or device trial
Both
18 Years and older
No
Contact: Renée Kochevar rkochevar@zoll.com
Germany,   Poland,   United Kingdom
 
NCT02070913
EDC-2191
No
ZOLL Circulation, Inc., USA
ZOLL Circulation, Inc., USA
Not Provided
Not Provided
ZOLL Circulation, Inc., USA
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP